1. Field of the Invention
This invention relates to a gastro-occlusive device, such as is useful for the treatment of morbid obesity and a variety of eating disorders.
2. Description of the Related Art
World-wide public health surveys and nutritional studies reflect a currently high and growing incidence of obesity in many countries.
The reasons for such pervasiveness of overweight individuals are numerous and include progressively increasing levels of sedentary behavior, ubiquity of processed high-fat, high-carbohydrate foods, increased automation of formerly manual activities, and decreased attention to physical fitness and exercise.
Although substantial efforts have been undertaken individually, governmentally and societally to ameliorate and reverse this trend, involving novel diets, food supplements, exercise equipment, nutritional regulations, psychological and counseling-based approaches, engineered foods, and many other interventional actions, such efforts have failed to address this serious and growing problem.
This problem is particularly serious in the case of individuals who are severely overweight (e.g., who exceed weight averages of applicable height/weight norms by 50% or more). For this segment of the overweight population, surgical intervention has been an increasingly preferred mode of resolving issues of excessive body weight. So-called “stomach stapling,” as a species of gastric reduction surgery, has become common as a mode of treatment of morbid obesity. This intervention involves closing off an upper portion of the stomach so that ingestion of small amounts of food produces satiety. In the surgical process termed vertical banded gastroplasty, the stomach is stapled vertically with rows of staples producing a reduced stomach volume typically constituting only a few tenths of a liter. A band then may be stapled to both walls of the stomach to prevent the stomach from stretching and to control the size of the stomach outlet. The stomach thereby is made smaller in volume, causing the patient to eat less while achieving a feeling of fullness, i.e., satiety.
Gastric reduction surgery has significant associated risks that impact its use and reliability. The stomach after the surgical procedure is still able to stretch, and staples can break and require additional emergency surgical intervention, since the detached staples may pose a life-threatening condition. Additionally, there are major side-effects to the surgery, including death, stroke, diarrhea, nausea, vomiting, chronic heartburn, and vitamin deficiencies. A significant portion of individuals who undergo gastric reduction surgery require a second operation to correct the side effects. There are other forms of gastric surgery, including laparoscopic adjustable gastric banding, which likewise has significant post-operative side effects.
Thus, although gastric reduction surgery is effective in many instances to provide a reduction in food intake and consequently of weight of the individual, it nonetheless carries significant health and safety risks that limit its use as a treatment option for morbid obesity.
It would therefore be a significant advance in the art to provide an alternative to gastric reduction surgery for the treatment of morbid obesity, which avoids the associated health and safety risks of conventional gastric reduction surgery.